Bavarian Nordic A/S (CPH:BAVA)(OTC:BVNRY), a fully integrated biotechnology company, announced on Tuesday positive results from a phase 3 pivotal study of its investigational, non-replicating smallpox vaccine, IMVAMUNE.

Reportedly, this study achieved both of its primary endpoints, demonstrating IMVAMUNE's efficacy in comparison to ACAM2000, the current US licensed replicating smallpox vaccine.

In this randomised, open-label study of 440 volunteers, neutralising antibodies induced by IMVAMUNE were shown to be two-fold higher than those stimulated by ACAM2000. This met the co-primary endpoint of non-inferiority and was even shown to be a statistically superior immune response. This phase 3 study enrolled 440 subjects at a US military garrison in South Korea led by the US Army Medical Research Institute of Infectious Diseases (USAMRIID) in collaboration with the US Defence Health Agency (DHA).

IMVAMUNE has been given to more than 7,800 subjects in 21 clinical studies, including two phase 3 studies that have supported a favourable safety profile and efficacy in comparison to replicating smallpox vaccines.

According to the company, it plans to file a Biological License Application in the second half of 2018. If approved, the company would also be eligible to receive a Priority Review Voucher, which could be used to accelerate the review of a future BLA and is also transferable.

Also, this phase 3 study comparing the safety and immunogenicity of IMVAMUNE to ACAM2000 has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No HHSO100200700034C.

IMVAMUNE is being developed as a smallpox vaccine for individuals for whom traditional replicating vaccines are contraindicated, such as people with atopic dermatitis (AD) and HIV. This vaccine is approved in Canada under the trade name IMVAMUNE and in the EU under the trade name IMVANEX as the only non-replicating smallpox vaccine approved for use in the general population.

Bavarian Nordic is focused on the development of innovative and safe therapies against cancer and infectious diseases.